Senior Director, CMC Project Management, Bioconjugate Modalities

About the role

The Senior Director, CMC Project Management provides strategic and operational leadership for cross-functional CMC teams. They partner with CMC scientific and technical leaders to ensure technical deliverables are met. This role leads the creation, development, communication, and implementation of integrated CMC plans for assets from portfolio entry to global submissions/approvals and launch.

Responsibilities

• Led the creation, development, communication, and implementation of integrated CMC plans for assets with the functional CMC areas from portfolio entry through global submissions, approvals, and launch.
• Leverage portfolio knowledge, development, and financial acumen to enable investment strategy and optimization at both project and portfolio levels.
• Drive cross-functional CMC teams to maximize the value of data, create bold, competitive plans, anticipate risks, effectively communicate risks, enable high quality decisions at fast speed, and implement decisions.
• Understand when and how to appropriately raise issues to teams and to stakeholders. Keep both team members and stakeholders fully apprised of project status and issues at the right level of detail.
• Mentor new PMs in the management of a development project: team dynamics, understanding stages of development and how functional inputs interact to ensure project progression, processes relating to CMC development, strategic document preparation, and PM best practices.
• Participate in or lead continuous improvement projects, which significantly impact the work and/or effectiveness of CMC development.

Requirements

• BS/BA degree in a scientific or engineering discipline with 10+ years of industry drug development/commercialization experience OR 5+ years of industry drug development experience with an advanced degree.
• Experience leading CMC development across the multi-component bioconjugate supply chain — including antibody intermediate, linker-payload, conjugation, and drug product — to align timelines, quality, and deliverables across internal teams and external partners.
• Succinct communicator with proficiency in English (written and spoken).
• Strong leadership, communication, risk management, and decision-making skills.
• Willing to relocate to Indianapolis, Indiana.

Qualifications

• Advanced degree strongly preferred (MS, MBA, PhD or PharmD).
• Demonstrated deep technical knowledge and experience of bioconjugate modality drug development, commercialization and manufacturing processes, including antibody drug conjugates (ADCs), antibody peptide conjugates (APCs), antibody RNA conjugates (ARCs), and/or peptide RNA conjugates (PRCs).
• Practical experience (formal or informal) in project management of cross-functional projects.
• Ability to lead cross-functional team(s) and together solve complex problems.
• Ability to rapidly become proficient in new tools.
• Demonstrated ability to communicate complex issues timely, accurately, and succinctly.